Dispensing mechanism for a medical device

ABSTRACT

A dispensing mechanism for administering a dosage of a medicament includes dosage setting means ( 7 ) for setting the dosage of a medicament to be administered; expelling means ( 15 ) for expelling a medicament from a medicament container; and coupling means ( 21 ) operatively coupled with the dosage setting means ( 7 ) and the expelling means ( 15 ), wherein the coupling means ( 21 ) is arranged to convert displacement of the dosage setting means ( 7 ) into a displacement of the expelling means ( 15 ) in a first direction, wherein the expelling means ( 15 ) includes a ratchet means ( 18   a,    18   b ), and wherein the mechanism includes a first and a second independently moveable resisting pawl ( 14   a,    14   b ) means facing a common side of the ratchet means ( 18 ), the first and the second resisting pawl means ( 14   a,    14   b ) being configured to engage with the ratchet means ( 18   a,    18   b ) and resist displacement of the expelling means ( 15 ) in a second direction opposite to said first direction.

The present invention relates to a dispensing mechanism foradministering a dosage of a medicament. The present invention alsorelates to a medical device comprising a dispensing mechanism, aninjection device comprising a dispensing mechanism and an inhalercomprising a dispensing mechanism.

Medical devices for administering medicament are known, for exampleliquid solutions or powders can be delivered to a user or patient usinginjection devices or powder inhalers respectively.

One such medical device for administering a liquid solution is aninjection device comprising a dispensing mechanism in which the dosageto be administered may be set by a dosage button moveable by a user orpatient. A subsequent further movement of the dosage button, typicallyin the proximal direction of the device, i.e. in a direction towards aninjection site of the device on the patient's skin, serves to inject themedicament using a ram to displace a plunger in a vial or cartridge ofliquid medicament. A needle is typically attached to the cartridge inorder to allow a subcutaneous delivery of the medicament. The dispensingmechanism ensures that a controlled and accurate dose may beadministered.

However, such drive mechanisms often include several interactingcomponent parts and thus packaging the components within a medicaldevice that is optimal in size to carry and simplicity to use can bedifficult. In addition, it cannot always be readily determined by a userof the device whether the correct dosage has been fully administered.

The present invention aims to alleviate at least to a certain extent atleast one of the problems of the prior art.

According to a first aspect of the invention, there is provided adispensing mechanism for administering a dosage of a medicament, themechanism comprising: a dosage setting means, element, part or parts forsetting a dose of medicament to be administered; expelling means,element part of parts for expelling a medicament from a medicamentcontainer; a coupling means, element, part of parts operatively coupledwith the dosage setting means and the expelling means, wherein thecoupling means is arranged to convert displacement of the dosage settingmeans into a displacement of the expelling means in a first direction,wherein the expelling means or coupling means includes a ratchet means,element, part or parts, and wherein the mechanism includes a first and asecond independently moveable resisting pawl means or pawls facing acommon side of the ratchet means, the first and the second resistingpawl means being configured to engage with the ratchet means and resistdisplacement of the expelling means in a second direction opposite tosaid first direction.

Advantageously, such a mechanism provides a compact arrangement andcontrol of the expelling means. The resisting pawl means advantageouslyprevents movement of the expelling means during dose setting.

The dosage setting means may comprise a push button or other componentwhich can be manually manipulated by a user.

Optionally, the ratchet means comprises a first and a second set ofteeth, the first set of teeth being arranged to engage with the firstresisting pawl means and the second set of teeth being arranged toengage with the second resisting pawl means.

The first and second sets of teeth are optionally each arranged in rows.The rows are optionally parallel and may be spaced from one another. Theteeth preferably comprise peaks and valleys. The ridges of the peaks ofeach set of teeth are aligned transverse to the longitudinal axis of theexpelling means. The teeth are preferably equally spaced in each row ofteeth. The heights of the teeth are preferably equal.

Each tooth preferably comprises a front planar face and a rear planarface. The front planar face is preferably arranged proximally, i.e.nearer the point of contact with a patient's skin, in use, in themechanism. The front face is preferably inclined at a smaller angle to aplane extending parallel to a side of the body of the mechanism ordevice and the rear face of each tooth being inclined at a relativelylarger angle to said plane.

The engaging faces are preferably the faces of the teeth against whichthe pawls may act to resist movement. The engaging faces are preferablythe rear faces of the teeth in each row of teeth.

The pawls may be orientated with their free, ratchet-engaging endsangled towards a first, proximal end of the mechanism.

Optionally, the dosage setting means is linearly displaceable in adirection substantially parallel to the longitudinal axis of theexpelling means.

Optionally, the dosage setting means is rotationally displaceable aboutan axis substantially parallel to the longitudinal axis of the expellingmeans.

Optionally, the dosage setting means is displaceable both axially androtationally about an axis parallel to the longitudinal axis of theexpelling means, for example where a screw thread arrangement isprovided.

Optionally, the first and/or second resisting pawl means comprise(s) orare formed with a part of a body of the mechanism.

Optionally, the mechanism may be formed of a plastics material, ametallic material or a combination of both.

Optionally, the teeth pitch in each of the first set of teeth and thesecond set of teeth is substantially equal.

Optionally, engaging faces of the second set of teeth are arrangedoffset from engaging faces of the first set of teeth on the ratchetmeans. Preferably, the offset is in the longitudinal direction of theexpelling means.

Optionally, the engaging faces of the teeth in the first set of teethare offset a distance of half the tooth pitch, i.e. half the distancebetween adjacent engaging faces from the teeth of the second set ofteeth. Preferably, the offset is in the longitudinal direction of theexpelling means.

Optionally, the resisting pawls are offset in the longitudinal directionof the expelling means. Optionally, the ratchet comprises a single setof teeth engageable with the resisting pawls. This allows for analternative arrangement in order to achieve fine dosages. Optionally,the offset of the resisting pawls may be, for example, 0.5 or 1.5 timesthe pitch or distance between adjacent teeth in the ratchet.

Advantageously, by arranging the teeth or pawls so that only one pawlengages with an engaging face of one of the two sets of teeth at any onetime, finer doses can be dispensed whilst the component features remainthe same size.

Optionally, the expelling means comprises a longitudinal member.

Optionally, the expelling means is formed with ribs, or protrusions tobe received in or be guided in corresponding recesses or channels. Thisensures smooth motion of the expelling means.

Optionally, the first and second resisting pawl means are formed onopposing parts of a body of the mechanism. This reduces the number ofcomponents and can provide strength to the resisting pawls.

Optionally, the body may be formed of two half-shells.

A dispensing mechanism is also provided, wherein the first and thesecond resisting pawl means are aligned in a substantially common plane.Alternatively, the first and the second resisting pawls means could bealigned offset with the teeth in the ratchet being in alignment.

Optionally, the first resisting pawl means is aligned adjacent thesecond resisting pawl means.

Optionally, the coupling means comprises a drive means or drivercomprising a pair of drive pawls engageable in said ratchet means fordisplacing said expelling means.

Optionally, the drive pawls are arranged in adjacent alignment or may beoffset corresponding to the offset of the resisting pawls.

Optionally, the coupling includes a guide slot in which a follower onthe drive means is received and configured such that the drive means ismoved as a result of movement of the dosage setting means. Optionally,the driver is caused to rotate about a pivot in order to engage thedrive pawls with the teeth in the ratchet and produce motion of theexpelling means.

Alternative coupling means may include gears or thread arrangements inorder to produce a displacement of the expelling means upon movement ofthe dosage means.

Optionally, the expelling means comprises a ram means.

According to a second aspect of the invention, there is provided adispensing mechanism for administering a dosage of a medicament, themechanism comprising: a body; and dosage setting means, element, part ofparts for setting the dosage of a medicament to be administered, thedosage setting means being moveable in a first direction for setting thedose and in a second direction for administering the dose, wherein themechanism further comprises an indication element, the indicationelement being arranged to be displaced by a predetermined movement ofthe dosage setting means; and wherein the indication element is arrangedsuch that the indication element remains unmoved relative to said bodyof the mechanism during at least part of said movement of the dosagesetting means.

In this way, the indication element can provide a static indication to auser for at least part of the motion of the dosage setting means. Thiscan serve to facilitate operation of the mechanism or device by a user.

Optionally, the indication element is movable within a guide channel.Advantageously, this maintains the orientation of the indicationelement.

Optionally, the indication element is slidingly supported in or on thebody.

Optionally, the dosage setting means is movable in an axial directionsubstantially parallel to the longitudinal axis of the body.

Optionally, the indication element is formed as a planar element,preferably as a generally rectangular plate or element.

Optionally, the dosage setting means is rotatable about the longitudinalaxis of the body.

Optionally, the dosage setting means is operative coupled to a first anda second engagement means, elements or parts, the first engagement meansand the second engagement means being engageable with the indicationelement such that upon engagement, movement of the dosage setting meanscauses displacement of the indication element.

The engagement means are preferably formed to engage with the indicationelement in order to move it with corresponding movement of the dosagesetting means.

Optionally, the engagement elements are arranged spaced from one anotherat a distance greater than a length of the indication element. This thenprovides a degree of lost motion of the indication element relative tothe dosage setting element.

Optionally, resisting means, elements or parts are provided, theresisting means being arranged to resist movement of the indicationelement relative to movement of the dosage setting means. This preventsmovement of the indication element until a predetermined movement of thedosage setting means has been made.

Optionally, the resisting means comprises a protrusion receivable in acorresponding recess. The protrusion may be provided on the body ordosage setting element or on the indication element or vice versa, forexample. This provides a degree of mechanical resistance withoutadditional parts.

Optionally, the resisting means comprises a protrusion receivable in acorresponding recess.

Optionally, the mechanism includes an aperture through which at least aportion of the indication element is exposed, in use, to a user.

Optionally, the indication element comprises tactile and/or visualindications. This may include Braille or other types of tactileindications and/or visual indications such as lights or printed numbers.The indications may indicate the state of the mechanism or device, e.g.whether a dose is ready to be administered or if a dose needs to be set.

Optionally, the indication element is moved directly by the dosagesetting means. The indication element may be in direct contact with thedosage setting means.

Optionally, the indication element is moved indirectly by the dosagesetting means.

According to a third aspect of the invention, there is provided adispensing mechanism for administering a dosage of a medicament, themechanism comprising: a body; dosage setting means, element, part orparts for setting the dosage of a medicament to be administered, thedosage setting means being moveable in a first direction for setting thedose and in a second direction for administering the dose; and anindication element, the indication element being arranged to bedisplaced by a predetermined movement of the dosage setting means; andwherein the mechanism further includes conversion means, element, partof parts configured, during displacement of the indication element, toconvert a movement of the dosage setting means of a first magnitude intoa movement of the indication element of a second magnitude, and whereinsaid first magnitude of movement is different to said second magnitudeof movement.

In this way, the degree of movement of the indication element can beconfigured to be different in magnitude to that of the dosage settingmeans.

Optionally, the first magnitude of movement is greater than the secondmagnitude of movement. In this way, a small movement of the dosagesetting means can cause a larger movement of the indication element.

Optionally, the first magnitude of movement is smaller than the secondmagnitude of movement. As such, the indication element can be arrangedto move a shorter distance that the movement of the dosage settingmeans.

Optionally, the conversion means is configured to move the indicationelement during all movement of the dosage setting means. The conversionmeans may be in constant contact with the dosage setting means or inconstantly coupled thereto, for example through an intermediatecomponent.

Optionally, the indication element remains unmoved relative to the bodyof the mechanism during at least part of said movement of the dosagesetting means.

Optionally, the indication element is movable within a guide channel.

Optionally, the indication element is slidingly supported in or on thebody.

Optionally, the dosage setting means is movable in an axial directionsubstantially parallel to the longitudinal axis of the body.

Optionally, the dosage setting means is rotatable about the longitudinalaxis of the body.

Optionally, the conversion means comprises a first and a secondengagement means operatively coupled to the dosage setting means, thefirst engagement means and the second engagement means being engageablewith the indication element such that upon engagement, movement of thedosage setting means causes displacement of the indication element.

Optionally, the engagement elements are arranged spaced from one anotherat a distance greater than a length of the indication element.

Optionally, the conversion means comprises a lever.

Optionally, the lever acts about a fulcrum operatively coupled to thedosage setting means. The relative magnitudes of movement of the dosagesetting means and indication element may be configured by the relativelengths of the lever either side of the fulcrum.

Optionally, the lever is reliantly flexible. In this way dimensionaltolerances may be accounted for as the lever may flex if movement of thedosage setting means is greater that the space in which the lever islocated.

Optionally, the lever is pivotally attached to said body.

Optionally, the lever is formed integrally with said body. This canserve to reduce manufacturing costs and reduce the number of parts inthe mechanism. The lever could alternatively be any part of the body,indicator or dose setting means, for example.

Optionally, resisting means are provided, the resisting means beingarranged to resist movement of the indication element relative tomovement of the dosage setting means.

Optionally, the resisting means comprises a protrusion receivable in acorresponding recess.

Optionally, the mechanism includes an aperture through which at least aportion of the indication element is exposed, in use, to a user.

Optionally, the indication element comprises tactile and/or visualindications.

Optionally, the indication element is moved directly by the dosagesetting means.

Optionally, the indication element is moved indirectly by the dosagesetting means.

According to a fourth aspect of the invention, there is provided adispensing mechanism for administering a dosage of a medicament, themechanism comprising: a dosage setting means, element, part or parts forsetting a dose of medicament to be administered; expelling means,element, part of parts for expelling a medicament from a medicamentcontainer; a coupling means, element, part or parts operatively coupledwith the dosage setting means and the expelling means, wherein thecoupling means is arranged to convert displacement of the dosage settingmeans into a displacement of the expelling means in a first direction,wherein the coupling means includes a ratchet means, element or part orparts comprises a first and a second ratchet wheels, and wherein themechanism includes a first and a second independently moveable resistingpawl means facing the ratchet means, the first and the second resistingpawl means being configured to engage with the first and second ratchetwheels respectively and resist displacement of the expelling means in asecond direction opposite to said first direction.

Advantageously, such a mechanism provides a compact arrangement andcontrol of the expelling means. The resisting pawl means advantageouslyprevents movement of the expelling means during dose setting.

Optionally, the first ratchet wheel comprises a first set of teeth andthe second ratchet wheel comprises a second set of teeth, the first setof teeth being arranged to engage with the first resisting pawl meansand the second set of teeth being arranged to engage with the secondresisting pawl means.

Optionally, engaging faces of the second set of teeth are arrangedrotationally offset from engaging faces of the first set of teeth on theratchet means. Each of the first and second ratchet wheels may haveteeth provided around their entire circumference. The first and secondratchet wheels preferably share a common rotational axis.

Optionally, the dosage setting means is linearly displaceable in adirection substantially parallel to the longitudinal axis of theexpelling means.

Optionally, the dosage setting means is rotationally displaceable aboutan axis substantially parallel to the longitudinal axis of the expellingmeans.

Optionally, the first and/or second resisting pawl means comprise(s) apart of a body of the mechanism.

Optionally, the angular teeth pitch in each of the first set of teethand the second set of teeth is substantially equal.

Optionally, the engaging faces of the teeth in the first set of teethare offset by an angle of rotation of half the angle of rotation betweenadjacent engaging faces from the teeth of the second set of teeth.

Optionally, the expelling means comprises a longitudinal member.

Optionally, the first and second resisting pawl means are formed onopposing parts of a body of the mechanism.

Optionally, the first and the second resisting pawl means are aligned ina substantially common plane.

Optionally, the first resisting pawl means is aligned adjacent thesecond resisting pawl means.

Optionally, the coupling means comprises a drive means comprising a pairof drive pawls engageable in said ratchet means for rotation of saidratchet wheel. The drive pawls may be spaced from one another to aligneither side of the expelling means.

Optionally, the drive pawls are arranged in adjacent alignment.

Optionally, the coupling includes a guide slot in which a follower onthe drive means is received and configured such that the drive means ismoved as a result of movement of the dosage setting means.

Optionally, the ratchet means comprises a gear wheel engageable with acorresponding set of teeth on the expelling means. The gear wheelpreferably shares a common axis of rotation with the ratchet wheels. Theteeth on the expelling means are preferably formed as a rack of teeth.The rotation of the gear wheel preferably results in axial movement ofthe expelling means.

Optionally, the first and second ratchet wheels are arranged either sideof said gear wheel.

Optionally, the diameter of the gear wheel is smaller than the diameterof each of the ratchet wheels. The ratchet wheels may be aligned eitherside of the expelling means. The gear wheel and ratchet wheel may beformed integrally as a single piece.

Optionally, the expelling means comprises a ram means.

Any one or more of the first to fourth aspects of the invention or anyoptional feature thereof may be combined. Advantages of the features areapplicable to different aspects and embodiments of the invention.

According to a fifth aspect of the invention, there is provided amedical device comprising a dispensing mechanism according to any of thefirst to fourth aspects of the invention and any optional featurethereof.

Optionally, the medical device may comprise a medicament container suchglass vial, cartridge or foil pack and/or a receiving part for such amedicament container.

According to a sixth aspect of the invention, there is provided aninjection device comprising a dispensing mechanism according to any ofthe first to fourth aspects of the invention and any optional featurethereof.

According to a seventh aspect of the invention, there is provided aninhaler comprising a dispensing mechanism according to any of the firstto fourth aspects of the invention and any optional feature thereof.

The present invention will now be described by way of an examplaryembodiment, with reference to the accompanying drawings, in which:

FIG. 1 shows a perspective view of a medical device with a dispensingmechanism comprising a dosage button in a depressed state;

FIG. 2 shows a perspective view of the medical device of FIG. 1 with adosage button in a withdrawn state;

FIG. 3 shows a first side perspective view of the medical device of FIG.1 with part of the outer body removed with the dosage button in adepressed state;

FIG. 4 shows a first side perspective view of the medical device of FIG.1 with part of the outer body removed with the dosage button in awithdrawn state;

FIG. 5 shows a first side perspective view of a drive pawl of themedical device of FIG. 1;

FIG. 6 shows a second side perspective view of the medical device ofFIG. 1 with part of the outer body removed with the dosage button in adepressed state;

FIG. 7 shows a second side perspective view of the medical device ofFIG. 1 with part of the outer body removed with the dosage button in awithdrawn state;

FIG. 8 shows a second side perspective view of a drive pawl of themedical device of FIG. 1;

FIG. 9 shows a perspective side view of the medical device of FIG. 1without a cartridge holder;

FIG. 10 shows a cutaway view through the body of the medical device asshown in FIG. 9 showing a rear view of a ratchet arrangement;

FIG. 11 shows a cutaway view through the body of the medical device asshown in FIG. 9, with the ratchet removed and showing the underside ofthe drive pawl;

FIGS. 12 and 14 show cross-sections A-A and B-B respectively of themedical device as is marked in FIG. 13 with the dosage button in adepressed state;

FIGS. 15 and 17 show cross-sections C-C and D-D respectively of themedical device as marked in FIG. 16 with the dosage button in awithdrawn state;

FIG. 18 a shows a side view of the ratchet of the medical device asshown in FIG. 1;

FIG. 18 b shows a detail view A as circled in the ratchet view shown inFIG. 18 a;

FIG. 19 a shows a plan view along the length of the ratchet as shown inFIG. 18 a;

FIG. 19 b shows a detail view B as circled in the ratchet view as shownin FIG. 19 a;

FIG. 20 shows a perspective view of the ratchet as shown in FIG. 18 a;

FIG. 21 shows a perspective side view of a medical device with anindicator window with a dosage button in a depressed state;

FIG. 22 shows a perspective side view of the medical device with anindicator window with the dosage button in a withdrawn state;

FIG. 23 shows a perspective view of the medical device shown in FIG. 21with part of the outer body removed;

FIG. 24 shows a side view of the medical device as shown in FIG. 21marking cross-section E-E;

FIG. 25 shows a cross-sectional view E-E of FIG. 21 showing the dosagebutton in an initial depressed state;

FIG. 26 shows a cross-section view E-E of FIG. 21 showing the dosagebutton in an initial retracted state;

FIG. 27 shows a cross-section view E-E of FIG. 21 showing the dosagebutton in an intermediate retracted state;

FIG. 28 shows a cross-section view E-E of FIG. 21 showing the dosagebutton in an fully retracted state;

FIG. 29 shows a medical device with an alternative dosage button in adepressed state;

FIG. 30 shows the medical device of FIG. 29 with the dosage button in arotated and retracted state;

FIG. 31 shows the medical device of FIG. 29 with the dosage button in arotated and depressed state;

FIG. 32 shows an external perspective view of a further medical devicewith the dosage button in a withdrawn state;

FIG. 33 shows a partial cross-section through the device as shown inFIG. 32;

FIG. 34 shows an external perspective view of the device of FIG. 32 withthe dosage button on a depressed state;

FIG. 35 shows a partial cross-section through the device as shown inFIG. 33;

FIGS. 36 to 39 show the medical device of FIGS. 32 and 33 in partialstages of assembly;

FIG. 40 shows a view of a further medical device comprising analternative dispensing mechanism with part of the body removed with apush button in a depressed state;

FIG. 41 shows a further view the medical device of FIG. 40 with the pushbutton in a retracted state;

FIG. 42 shows a view of the coupling means and expelling means of thedispensing mechanism shown in Figures and 41; and

FIG. 43 shows a view of a rotary ratchet of the expelling means of thedispensing mechanism of FIG. 42.

FIG. 1 shows a perspective view of a medical device including adispensing mechanism generally indicated 1. The medical device 1comprises an elongate body 2 with a substantially square cross-sectionwith rounded edges between adjacent sides. However, it is envisaged thatthe body 2 may be formed in any suitable shape, for example with acircular cross-section or with varying cross section along the length ofthe device 1.

The size and the form of the body 2 may be designed to facilitate beingheld in a user or patient's hand. The surface may be provided withsurface protrusions or knurling or any other such surface texture tofacilitate gripping of the device 1.

At a first, proximal end 3 a of the body 2, i.e. the end nearest aninjection site of a user in use, a cartridge receptacle 4 is attached,for example by a bonded or clipped engagement, to the body 2, forholding a medicament cartridge or carpule. The cartridge receptacle 4 isformed generally as a truncated cone and may be made transparent inorder that a user may inspect the contents of the medicament cartridgeto obtain a visual indication of the quantity of medicament remaining.The medicament cartridge may be filled with a liquid medicament, forexample insulin.

A removable and disposable needle (not shown) may be attached to thecartridge receptacle 4 or to a threaded engagement 5 provided on theouter surface of a cylindrical part at the proximal end of the cartridgewhich, as shown in FIG. 1, extends through the end of the cartridgereceptacle 4. A typical needle comprises a rear needle part forpuncturing a plastic stopper 6 provided at the proximal end of themedicament cartridge. The needle also comprises a forward needle part.In use, the forward needle part may be inserted subcutaneously into apatient so that medicament may be injected from the medicament cartridgeinto a patient.

At a second, distal end 3 b of the body 2 of device 1, i.e. the end, inuse, furthest from an injection site of a user, a dosage setting meansor element is provided in the form of a push button 7. In theembodiment, the push button has a similar, generally square,cross-sectional shape to that of the body 2 of the device 1. However,different shapes and arrangements of the dosage means are envisaged. Thedosage means 7 is typically sized to be gripped between a finger andthumb of a user. FIG. 1 shows the push button 7 in a depressed, i.e.pushed-in state relative to the body 2 of the device 1.

The push button 7 may be pulled out away from the body 2 in a firstdistal direction in order to set a dose and pushed in towards the body 2in a second proximal direction in order to administer a dose ofmedicament.

In FIG. 2, the push button is shown in a first, pulled-out state, withthe device ready to deliver a dose. The push button 7 comprises a driveshaft 8 connecting the push button to a drive mechanism within the bodyof the device.

The body 2, in the embodiment, is formed of two half-shells 2 a, 2 b.The body 2 is generally formed of a plastics material, which may beinjection moulded or produced by any other suitable manufacturingtechnique.

FIG. 3 shows the device 1 with one of the half-shells 2 b removed toexpose the internal drive mechanism of the device 1.

Within the body 2 of the device 1, an expelling means, element or partis provided in the form of a longitudinal drive rod 15. The rod 15 islinear in form and serves as a ratchet or ratchet means, with an uppersurface comprising two sets of ratchet teeth 18 a, 18 b extending alongat least part of the length of the rod 15. The teeth are orientated suchthat their lands, valleys or ridges of the peaks run transverse to thelongitudinal direction of the device.

In the exemplary embodiment described herein, the teeth of one of thesets of ratchet teeth are offset from the teeth of the other set ofratchet teeth. However, it should be noted that such an ‘offset’arrangement is only a preferred embodiment of the present invention.

The sets of ratchet teeth in this example are separated by alongitudinal planar divider 24. The longitudinal rear side of the rod 15is planar with a central protruding guide rib 20. Corresponding channelsand support rails 23 a, 23 b are formed within the body 2 to receive therod 15 and the guide rib 20 and allow linear movement thereof along thelongitudinal axis of the device 1.

At the proximal end of the rod 15, the rod comprises an engagement ram16 a in the form of a circular disc. The ram 16 a is formed and sizedsuch that, in use, the ram 16 a can engage with and displace a plunger17 in a medicament cartridge received in the cartridge receptacle 4.

A coupling means, element, part or mechanism is provided to couple thedosage setting element with the expelling element. In the embodiment,the coupling means includes a first coupling element 22 connected to thepush button 5 via a shaft 8. In the embodiment, the first couplingelement 22 is formed integrally with the shaft 8. However, it isenvisaged that the coupling element 22 could be operatively coupled tothe push button 7 and/or shaft via a sprung or biased coupling so as tobe moveable relative thereto.

The coupling element 22 comprises a pair of spaced planar sections ofwhich only the upper planar section 9 a is visible in FIG. 3. However, acorresponding lower planar section is formed with the lower side of theshaft of the push button 7. The spaced planar sections 9 a areperpendicular to the plane of the surface on which the ratchet teeth areprovided. In the upper planar section 9 a of the coupling element 22, adiagonal slot 10 a is provided. The diagonal slot 10 a extendsdiagonally in a direction across the body of the device.

The coupling further comprises a drive means or driver 21 which, asshown more clearly in FIG. 5, comprises a pair of parallel and spacedplanar arms 12 a, 12 b connected via a transverse web 16 b towards aproximal end thereof. Each of the planar arms 12 a, 12 b comprises acircular protrusion or follower of which only the upper protrusion 11 ais visible in FIGS. 3 to 4.

The circular protrusion 11 a of the upper planar arm 12 a is received inthe diagonal guide slot 10 a of the upper planar section 9 a of thecoupling element. Although not shown, a corresponding circularprotrusion is formed on the lower planar arm 12 b and is received in acorresponding diagonal guide slot 10 a in the lower planar section ofthe coupling element 22.

The underside of the upper planar section 9 a of the coupling element 22is supported on and slides atop of the upper planar arm 12 a of thedriver 21.

The driver 21 comprises a pair of drive pawls 14 a, 14 b extending fromthe web 16 b. A gap is provided between the drive pawls 14 a, 14 b whichfits around the divider 24 between the two sets of ratchet teeth 18 a,18 b. The drive pawls are independently flexible about their connectionwith the driver 21.

The driver 21 comprises a cylindrical portion 13 a which is pivotallylocated in a corresponding hole in the body 2 of the device 1. Thecylindrical portion is rotatably engaged with the hole in the body 2such that the driver 21 may rotate about the axis of the cylindricalportion, which acts therefore as a pivot axis.

The drive pawls 14 a, 14 b are arranged such that they can engage with atooth respectively of each of the sets of ratchet teeth 18, although dueto the offset in the sets of teeth, the drive pawls 14 a, 14 b do notnecessarily contact the same part of a tooth in a respective set ofteeth. For example, with an offset arrangement of the two sets of teethin the drive rod, one drive pawl may be in engagement with a rear faceof a tooth and the other drive pawl may be atop a ridge or peak of atooth in the adjacent set of teeth. The drive pawls 14 a, 14 b of thedriver 21 are angled towards the proximal end 3 a of the body 2 ofdevice 1. However, embodiments are envisaged where the teeth in each setof teeth are in adjacent alignment.

FIG. 4 shows a further view of the device 1 as shown in FIG. 3 with thepush button 7 in a retracted or withdrawn position.

As can been in FIGS. 3 and 4, in the depressed state of the push button7, the engagement protrusion 11 a of the driver 22 is located at oneend, the distal end, of the diagonal slot 10 a of the coupling element22. In the withdrawn position of the push button 7, the engagementprotrusion 11 a of the driver 22 is located at the other end, theproximal end, of the diagonal slot 10 a of the coupling element 22. Thischange of position is achieved by the engagement protrusion 11 a slidingin the diagonal slot 11 a as the push button 7 is moved in a directionalong the longitudinal axis of the device.

Because of the diagonal orientation of the slot 11 a in the couplingelement, the movement of the engagement protrusion 11 a, which is formedwith the driver 21, causes the driver 21 to rotate about the pivot pointformed by the engagement of the cylindrical protrusion 13 of the driver21 engaged in the body 2 of the device 1.

As the driver 21 is rotated clockwise about the pivot axis 13 by thepush button 7 being depressed, one of the pawls 14 a, 14 b engages withat least one rear face of a tooth on one of the sets of ratchet teeth18a such that the longitudinal rod 15 is displaced in a directiontowards the distal end of the device.

FIGS. 6, 7 and 8 show reverse side perspective views respectively of theviews shown in FIGS. 3, 4 and 5.

In FIG. 6, the device 1 is shown with the push button 7 in a depressedstate. The longitudinal drive rod 15 can be seen showing the upper sidethereof in which the two sets of ratchet teeth 18 a, 18 b are providedseparated by divider 24. The upper and lower drive pawls 14 a, 14 b canbe engaged with teeth respectively in the first and second sets ofratchet teeth 18 a, 18 b, although as described above, due to the offsetof the teeth in the two sets of teeth 18 a, 18 b, the drive pawls 14 a,14 b do not necessarily contact the same portion of a tooth in arespective set of teeth.

FIG. 7 shows the device 1 with the push button 7 in a withdrawn state.As can be seen from FIG. 6, with the push button 7 in a depressed stateor position, the driver 21 has been rotated about the pivot axis 13 thusengaging at least one of the drive pawls 14 a, 14 b with at least onerear face of a tooth of a set of ratchet teeth 18 a, 18 b and causingthe drive rod 15 to be displaced in a proximal direction.

The drive pawls 14 a, 14 b are formed to allow a degree of flexingrelate to the web 16 b.

FIG. 9 shows a view of the device 1 with the push button 7 in adepressed state. The device 1 is shown with the cartridge receptacle 4removed. An aperture 25 can be seen in the proximal end 3 a of the body2 in which the drive rod 15 may extend in use to engage with the stopperof a medicament cartridge (not shown).

FIG. 10 shows a view of the device 1 with a cut-out in the body 2.Through the cut-out, the drive rod 15 may be seen. Either side of thedrive rod 15, the upper and lower arms 12 a, 12 b of the driver arelocated. The upper and lower drive pawls 14 a, 14 b can also be seen.

Spaced from the upper and lower drive pawls 14 a, 14 b, in the proximaldirection of the body 2 of the device 1, a pair of resistance orresisting pawls 26 a, 26 b is provided. The resistance pawls 26 a, 26 bare formed with or attached to the body 2 of the device 1.

FIG. 11 shows a further cut-away view of the body 2 of the device 1, butwith the drive rod 15 removed. Here, the arrangement of the resistancepawls 26 a, 26 b and drive pawls 14 a, 14 b can be seen.

The resistance pawls 26 a, 26 b are angled in a direction towards theproximal end 3 a of the body 2 of device 1. The resistance pawls areflexible to a certain degree with respect to the body 2 of the device 1.

The upper resistance pawl 26 a can engage with the upper set of teeth 18a on the longitudinal rod 15, with the lower resistance pawl 26 bengageable with the lower set of teeth 18 b on the longitudinal rod 15.Due to the offset of the teeth between the teeth in one set of ratchetteeth to the teeth in the other set of ratchet teeth in this embodiment,the resistance pawls 26 a, 26 b may not contact the same part of a toothin each of the first and second sets of ratchet teeth 18 a, 18 b.

The resistance pawls 26 a, 26 b serve to resist or prevent movement ofthe longitudinal rod 15 in a direction away from the proximal end 3 a ofthe body 2 of device 1, by engaging the rear faces of the ratchet teeth18 a, 18 b.

The operation of the device 1 will now be described with reference toFIGS. 12 and 14, which show cross sections A-A and B-B along theparallel longitudinal planes shown in FIG. 13.

FIGS. 12 and 14 show the device 1 with the push button 7 in a depressedstate. A medicament cartridge 27 is shown within the cartridgereceptacle 4. A plunger 17 is provided within the medicament cartridge27 which can be moved by engagement and displacement of the ram 16a ofthe longitudinal or drive rod 15, which serves to expel the medicamentfrom the cartridge 27. FIG. 14 is a lower side view of the device 1 andthe description of the upper side as shown in FIG. 12 is equallyapplicable to the lower side.

The upper resistance pawl 26 a and the distal edge thereof can be seenengaged with a rear face of a tooth of the upper set of ratchet teeth 18a on the longitudinal drive rod 15.

The upper drive pawl 14 a can also be seen engaged with a rear face of atooth of the upper set of ratchet teeth 18 a on the longitudinal ordrive rod 15.

In order to set a dose, a user must withdraw the push button 7 in adirection away from the cartridge receptacle 4, i.e. in a distaldirection with respect to the body 2 of device 1.

As the push button 7 is withdrawn, as has been described in relation toFIGS. 3 to 8, the sliding or engagement protrusion 11 a on the upperdrive arm 12 a of the driver, which is located in the diagonal slot 10 aof the coupling element 22, slides in the slot, causing the driver 21 torotate in an anti-clockwise direction about the pivot axis 13. Duringthis movement, due to the offset of the sets of ratchet teeth 18 a, 18b, one of the resistance pawls 26 a, 26 b acts to resist movement of thedrive rod 15 in a distal direction by engagement with the rear face ofthe tooth.

As the driver 21 rotates, one of the drive pawls 14 a, 14 b slides frombetween a space or valley between two longitudinally adjacent peaks oftwo teeth, over the front tooth face and ridge of a tooth such that itproceeds to be located in the longitudinally adjacent space or valleybetween successive teeth. The other of the drive pawls also moves, butdue to the offset in the sets of ratchet teeth 18 a, 18 b does notnecessarily end up on the same part of a tooth. At this stage, the pushbutton is then in a retracted state as shown in FIGS. 15 and 17 whichshow cross sections D-D and C-C along the parallel longitudinal planesshown in FIG. 16.

Upon the subsequent displacement of the dosage setting means 7 towardsthe proximal end 3 a of the body 2 of device 1, the sliding protrusion11 a moves along the slot 10 a in the coupling 22. As a result, thedriver 21 rotates in a clockwise direction about the pivot point 13. Oneof the drive pawls 14 a, 14 b on the driver 21, normally a drive pawlpositioned behind a peak of a tooth, engages with the rear face of thetooth in the set of ratchet teeth 18 a, 18 b in which it is located suchthat the longitudinal rod is displaced upon further movement of thedosage setting means in an axial direction in order to administer adosage of medicament.

This operation, i.e. the continued withdrawal and subsequent depressionof the push button 7, serves to move the drive pawls 14 a, 14 bsuccessively into subsequent valleys or spaces between the teeth anddrive the drive rod 15 towards the proximal end 3 a of the body 2 ofdevice 1. After the drive pawl reaches the surface 28 a, 28 b after thelast tooth of the drive rod 15, no further displacement can be made.

The resistance pawls 26 a, 26 b are fixed to the body 2 of the device 1and serve to resist or prevent movement of the drive rod (“expellingmeans”) 15 in a direction opposite to the administering direction, i.e.in a direction towards the proximal end 3 a of the body 2 of device 1.This ensures a consistent displacement of the drive rod 15 in theproximal direction only and prevents backlash or displacement of thedrive rod 15 in the distal direction.

All of the sets of ratchet teeth 18 a, 18 b are provided on a commonside of the drive rod 15 and therefore all the resistance pawls 26 a, 26b and drive pawls 14 a, 14 b are arranged to face a common side of thedrive rod.

As the drive rod 15 is displaced in the proximal direction of the device1, the resistance pawls 26 a, 26 b slide over the ratchet teeth 18 a, 18b on the drive rod 15.

FIGS. 18 a, 19 a, 20, show more detailed side, plan and perspectiveviews of adrive rod 15 having offset sets of teeth.

The drive rod 15 comprises two sets of ratchet teeth 18 a, 18 bseparated by a divider 24. The two sets of ratchet teeth 18 a, 18 b areoffset, i.e. engaging faces of the upper set of ratchet teeth 18 a, areoffset from the engaging faces of the lower set of ratchet teeth 18 b ina direction parallel to the longitudinal axis of the drive rod 15. Thiscan be more clearly seen in details A and B shown in FIGS. 18 b and 19b.

As shown in FIG. 18 b, each tooth has a ridge or peak 29 c, a slidingfront face 29 a over which the pawls slide and an engagement rear face29 d as well a valley centre 29 b. The teeth in each set of ratchetteeth 18 a, 18 b on opposing sides of the expelling means are equallyspaced from one another. The offset between the two sets of ratchetteeth 18 a, 18 b in the embodiment is equal to half the spacing betweenadjacent teeth in either of the first or second sets of ratchet teeth 18a, 18 b.

In the embodiments described, the upper and lower resistance pawls 26 a,26 b are arranged in adjacent alignment. Similarly, the upper and lowerdrive pawls 14 a, 14 b are also arranged in adjacent alignment. Due tothe offset of the two sets of ratchet teeth 18 a, 18 b on the drive rod15, when driving the driver 21, as described above, during each sequenceof withdrawing the push button 7 and subsequently depressing the pushbutton 7, only one set of resistance pawl 26 a and drive pawl 14 aengage fully with one set of the ratchet teeth, i.e. only one of thedrive pawls 14 a causes the drive rod 15 to be displaced and only one ofthe corresponding resistance pawls 26 a prevents return movement of thedrive rod 15. During a subsequent sequence, the other set of drive pawl14 b and resistance pawl 26 b fully engages with the other set ofratchet teeth 18 b, and so on.

Accordingly, the offset of the ratchet teeth 18 a, 18 b provides aratchet with finer resolution of movement, which is equal to thedistance between the valley of one tooth in one of the sets of ratchetteeth 18 a and the valley of an adjacent tooth in the other of the setsof ratchet teeth 18 b. This offset is shown in FIG. 19 b at item 30.

It follows that movement of the drive rod 15 in the embodiment describedproceeds in smaller increments than if no offset were to be providedbetween the two sets of ratchet teeth 18 a, 18 b. This enables a finerdose or volume of medicament to be administered with the device 1 as aresult of movement or displacement of the drive rod 15.

The offset in the case of a drive rod 15 with offset sets of ratchetteeth 18 a, 18 b may be adjusted according to requirements. For example,a drive rod 15 may be chosen with a larger tooth pitch in the sets ofratchet teeth in order to administer a large dosage during each cycle ofmovement. Conversely, a smaller pitch could be chosen. The othercomponents however generally remain the same.

As previously mentioned, a drive rod 15 where the sets of ratchet teethare in alignment is also envisaged. In such an embodiment, both drivepawls and resistance pawls would be in engagement with correspondingparts of teeth in each set of teeth at the same time in order to drivethe expelling means and resist movement of the expelling means in thedistal direction of the device.

With all of these embodiments, providing the ratchet teeth 18 a, 18 b ona single, common side of the drive rod 15 enables a more compact andsimple device construction to be achieved.

As an alternative to offset teeth on the drive rod 15 , the adjacentratchet teeth may be aligned with the drive pawls offset from oneanother. Indeed, a single set of ratchet teeth can be provided which canengage with each of the drive pawls and each of the resistance pawls.

It is envisaged that other coupling mechanisms may be provided todisplace the drive rod and the present invention should not beconsidered limited to the exemplary coupling mechanism as shown in theFigures.

FIGS. 21 and 22 show a further embodiment of the device 1 having anindicator element 34 visible through a display window or aperture 31provided in a surface of the body 2 of the device. FIGS. 21 and 22 havedrive mechanisms configured to drive a drive rod 15 as described abovein relation to FIGS. 1 to 20. However, the indicator element 34 anddisplay window 31 arrangement of FIGS. 21 and 22 may be applied todevices with different drive mechanisms, including inhaler devices (notshown).

FIG. 21 shows the device 1 with the push button 7 in a depressed state.In this position of the push button 7, a first state indicator 32 a of“0” provided on the indicator element 34 is visible in the window 31.This first state indicator 32 a could for example indicate to a userthat no dosage has been set by the push button 7.

FIG. 22 shows the device 1 with the push button 7 in a withdrawn orretracted state. In this position of the push button 7, a second stateindicator 32 b of “5” provided on the indicator element 34 is visiblethrough the window 31. This second state indicator 32 b could forexample indicate to a user that a dosage of 5 units has been set foradministration. Of course, other indications of state could be providedsuch as arrows or other visual or tactile markers or characters.

FIG. 23 shows a view of the device 1 with part of the body removed toshow the internal drive mechanism and also the mechanism to move theindicator element 34. The drive mechanism includes a driver 21 rotatableabout a pivot axis 13. The driver 21 includes a protrusion 11 a whichengages through a diagonal, linear slot in a coupling element 22. Thedriver 21 drives a drive rod 15 provided with sets of ratchet teeth 18a, 18 b. The drive rod 15 comprises a ram 16 a which can be extended ordisplaced through an aperture 25 in order to displace a plunger in amedicament container such an insulin cartridge (not shown). The functionof such a mechanism has already been described in relation to FIGS. 1 to20 and will not be described further here.

The coupling 22 includes a planar surface 9 a, as described above. Thesurface 9 a is provided with distal and proximal protrusions 33 a, 33 b,which are spaced apart a distance greater than the axial length of theindicator element 34, which is disposed in the body 2 between saidprotrusions 33 a, 33 b.

A protrusion 35 c is provided along an edge of the window 31, theprotrusion 35 c being configured to engage with each of two spacedindents 35 a, 35 b located along an edge of the indicator element 34parallel to the direction of movement of the indicator element 34. Whenengaged with either of the indents 35 a, 35 b, the protrusion 35 c actsto inhibit free axial linear movement of the indicator element 34, whichin this embodiment is formed as a substantially rectangular planarelement.

The indents 35 a, 35 b and the protrusion 35 c combine with protrusions33 a, 33 b on the body 2 to form motion conversion means, the functionof which will now be described with reference to FIGS. 25 to 28 whichare sectional views through section E-E as shown in FIG. 24.

When the push button 7 of the device is fully depressed into the body 2of the device, as shown in FIG. 25, the indicator element 34 ispositioned with its distal edge engaged with protrusion 33 a towards therear or distal end of the device body 2. The indication “0” is shown inthe window 31, represented by the dashed outline.

Upon initial withdrawal of the push button 7, as shown in FIG. 26, theindicator element 34 remains stationary relative to the body 2 of thedevice thanks to protrusion 35 c along the edge of window 31 engagingwith rearmost indent 35 a of the indicator element 34. This engagementacts to resist axial movement of the indicator element 34 relative tothe body 2 such that the indicator element 34 slides over the surface ofthe coupling 22 when during an initial movement of the push button 7and, as there is no movement of the indicator element 34 relative to thebody 2, the indication “0” remains visible to a user through window 31,indicating, for example, that the dosage has not yet been set.

Upon further withdrawal of the push button 7, as shown in FIG. 27, theproximal protrusion 33 b engages with the proximal edge of the indicatorelement 34, which causes the indicator element 34 to be displaced in adistal axial direction of the body 2 of the device, in doing soovercoming the resistance provided by the engagement of the protrusion35 c and distal indent 35 a, such that the indication “0” 32 a begins tomove out of visibility in the window 31.

FIG. 28 shows the fully retracted position of the push button 7. Here itcan be seen that the proximal protrusion 33 b on the coupling 22maintains its engagement with the indicator element 34 therebycompleting the axial movement of the indicator element 34 to bringindication “5” 32 b into visibility in the display window 31. This couldfor example indicate to a user that the dosage has been correctly setand the push button 7 could be depressed in order to administer thedose. In this final fully withdrawn position of the push button 7, theprotrusion 35 c along the edge of window 31 becomes engaged with theforemost indent 35 b on the edge of the indicator element 34.

Upon subsequent depression of the push button 7 in order to administer adose, the indicator element 34 again initially remains stationaryrelative to the body 2 due to the resistance of protrusion 35 c beingengaged with the foremost indent 35 b on the edge of the indicatorelement 34 such that the indication “5” 32 b remains visible in thewindow 31 during an initial movement of the push button 7. This could,for example, indicate to a user that the dose has not yet been fullyadministered.

Similarly as when the push button 7 is withdrawn, upon continueddepression of the push button 7, the distal protrusion 33 a on thecoupling 22 engages with the corresponding distal edge of the indicatorelement 34 thereby to move it in the proximal direction relative to thebody 2 of the device such that the indication “0” 32 a is againdisplayed in the window 31 and protrusion 35 c again engages withrearmost protrusion 35 a on the edge of the indicator element 34.

Although in the embodiment, the indicator element 34, here in the formof a sliding indicator, has been provided with indents 35 a, 35 b ateach end of travel, it is also envisaged to provide a protrusion on theedge of the sliding indicator 34 which engages with correspondingindents provided on a corresponding edge of the window 31.

It will be understood that the mechanism provides a magnitude ofdisplacement of the indication element 34 which is different to (i.e.less than) the magnitude of displacement of the dosage setting means. Inthe embodiment, the spacing of the protrusions 33 a, 33 b on the surface9 a of coupling 22 provides a relative or “lost motion” movement betweenthe push button 7 and the indicator element 34. This allows theindications 32 a, 32 b to remain visible and unchanged during phases ofthe operation of the device. This can lead to improved operation of thedevice as the displayed indications 32 a, 32 b remain consistent andunchanged.

While in the embodiment, an axially moveable push button 7 has beenshown to provide drive of the mechanism, other forms of dosage settingmeans may be provided such as a dial, rotatable about the longitudinalaxis of the device while still embodying the above-described arrangementof the indicator element 34. An example of such a dosage setting meanswith a rotating dial 36 on a cylindrical body 37 is shown in FIGS. 29 to31 in a fully screwed in position in FIG. 29, a fully retracted, i.e.screwed-out position in FIG. 30 and a fully depressed position in FIG.31.

A further embodiment of a device 1 is shown in FIGS. 32 to 39 comprisinga different indicator element arrangement. Externally, the device 1 isformed similarly to the embodiments described above, comprising a body2, a cartridge receiver 4, a cartridge with a threaded portion 5 forreceiving an injection needle, a push button or dosage means 7 and awindow or aperture 31. Through the window 31, an indication, here thenumber “5” is visible, which is on an indicator element 42.

FIG. 33 shows a cross-section through the device shown in FIG. 32. Thedispensing mechanism is similar to that shown in FIGS. 1 to 31 andcomprises a driver 21 with drive pawl 14 a, 14 b and resistance pawls 26a, 26 b arranged to engage with ratchet teeth 18 a, 18 b on a drive rod15.

A coupling element 38 is provided, which comprises a diagonal slot 10 awithin which a protrusion 11 a is received. These parts functionsimilarly to the coupling element 22 described in relation to FIGS. 1 to31 in order to set a dose with the push means 7 and administer a dose.The dosage and administering functions will accordingly not be describedfurther here.

In contrast to the device of FIGS. 1 to 31, as shown in FIG. 33, thecoupling element 38 comprises a rectangular aperture 43. Along one edgeof the aperture, an opening 45 is provided in which a conversion meansin the form of lever 39 is positioned. The lever 39 extends through theopening 45 into the aperture 43 from a pivoted connection 40 on the body2 located outside the aperture 43.

The indicator element 42 is provided with a pair of spaced protrusions,represented by the dashed lines 41 a, 41 b. The protrusions 41 a, 41 bextend from the rear surface or underside of the indicator element 42(not shown in FIG. 33 or 35) and are positioned towards either end ofthe indicator element 42 in the longitudinal direction of the device.When assembled, the protrusions 41 a, 41 b extend into the aperture 43such that they are positioned either side of the distal end of the lever39, i.e. the end of the lever 39 furthest from the pivoted connection40, such that the indicator element 42 rests atop the lever 39.

FIG. 33 shows the device with the push button 7 in a retracted position.Here it can be seen that the lever 39 is in contact with the rearmost ordistal protrusion 41 b of the indicator element 42 and is orientatedsuch that the lever 39 is angled towards the distal end of the body 2.

FIG. 34 shows an external view of the device of FIGS. 32 and 33 when thepush button 7 is in a fully depressed position. In this position, theindicator element 42 now shows the indication “0”. As has been describedin relation to FIGS. 28 to 31, the indication “0” can be used toindicate to a user that no dose has been set and the indication “5” canbe used to indicate that a dose of 5 units has been set, for example.

As can be seen in FIG. 35, with the push button 7 in a fully depressedstate, the rectangular aperture 43 has been axially displaced in theproximal direction of the device relative to the position of therectangular aperture 43 of the device in the state shown in FIG. 33. Itcan be seen that the opening 45 in the side of the aperture 43 hastherefore also moved in a corresponding towards the proximal end of thebody 2. As the lever 39 is pivotally attached to a fixed pivot 40 on thebody of the device, the movement of the aperture 43 and the opening 45therein causes rotation of the lever 39 about the pivot 40. As thedistance between the pivot 40 and the opening 45 is less than thedistance between the opening 45 and the distal end of the lever 39, itcan be appreciated that a movement of the aperture 43 results in amovement of the distal end of the lever 39 of a greater magnitude, whichmoves the indicator element 42, via the protrusions 41 a, 41 b, acorresponding distance. Thus it can be seen that the opening 45 acts asa fulcrum 43.

The relative lengths of the lever 39 between the pivot 40 and thefulcrum 43 and the length between the fulcrum 43 and the distal end ofthe lever 39, or its point of contact with the protrusions 41 a, 41 b ofthe indication element 42, may be selected to produce a desiredmagnitude of movement of the indication element 42 relative to thedosage setting means 7.

As shown in FIG. 35, in the depressed state of the push button 7, thedistal end of the lever 39 is in contact with the protrusion 41 a of theindicator element 42 towards the proximal end of the body 2 and hasmoved the indicator element 42 such that the indication “0” is nowvisible in the aperture or window 31 as shown in FIG. 34.

The lever 39 acts to convert a movement of a first magnitude of the pushbutton 7 or coupling 38 into a movement of a second, greater magnitudeof the indicator element 42. In a device with limited space, the lever39 can provide a greater movement and functionality of the indicatorelement 42 than if the movement of the indicator element 42 was limitedonly to the same magnitude or degree of movement of the push button 7.For example, a 4 mm movement of the indicator element 42 can result fromjust a 2 mm axial movement of the push button 7, thereby providing a“gained motion” effect.

It will be understood however, that the opening 45 or fulcrum 43 andlever 39 may be arranged with a shorter distance between the opening 45and the distal end of the lever 39 than the distance between the pivotedend 40 of the lever 39 and the opening 45 such that a smaller magnitudeof movement of the indicator element 42 is achieved relative to themagnitude of movement of the push button 7.

As a further alternative, the lever 39 may be formed of a resilientlyflexible material such that when the indicator element 42 reaches thelimit of its movement, if the lever 39 should be caused to rotatefurther, for example if the manufacturing tolerances of the lever 39 aresuch that it is slightly longer or wider than necessary or if thefulcrum 43 or opening 45 position is not precisely located, the lever 39will flex to prevent damage to itself or to the indicator element 42.

FIGS. 36 to 39 show some assembly steps of the device with the lever.FIG. 36 shows the body, driver 21 and drive rod 15 located in the body2. The body 2 is formed with a circular aperture 40 for receiving asupport 44 of the lever 39.

FIG. 37 shows the support 44 of the lever 39 located in the aperture 40.The lever 39 is pivotable about the axis of the circular aperture 44.Although shown in FIG. 37 as a separate part in the embodiment, thelever 39 could be formed integrally with the body 2, yet still able topivot.

FIG. 38 shows the device with the coupling 38 attached to the pushbutton 7 fitted. The lever 39 can be seen located in the opening 45provided along one longitudinal side of the rectangular aperture 43.

Finally, FIG. 39 shows the indicator element 42 positioned atop thecoupling 38 and hence lever 39. The indicator element 42 is formed withthe lever-engagable protrusions 41 a, 41 b underneath, which were shownand described in relation to FIGS. 33 and 35.

The indicator element 42 is shown provided with indents 46 a, 46 b,which have a similar function to the indents 35 a, 35 b described inrelation to FIGS. 23 and 25 to 28 to resist free motion of the indicatorelement 42.

Although not shown in the Figures, it is envisaged that instead of alever 39, the conversion means could comprise geared or threadedcomponents, with the gearing or threading being chosen or configuredsuch that a predetermined magnitude of movement of the indicator element34 is achieved for a predetermined differing magnitude of movement ofthe push button 7.

In each of the aforementioned embodiments, the dosage setting means 7could be indirectly or directly coupled to the indication element 34,42. The indicator element 34, 42 is typically constrained within achannel or guide elements to limit the lateral movement thereof.

FIG. 40 shows an alternative dispensing mechanism provided in a device1. The device 1 includes a medicament container in the form of acartridge receptacle 4. Within the cartridge receptacle 4, a cartridgeis contained with a screw thread 5 at the proximal end to receive aneedle.

Similarly to the embodiments shown in FIGS. 1 to 39, the dispensingmechanism comprises a dosage setting means in the form of a push button7. The dosage setting means is formed with a shaft 8 connecting the pushbutton 7 with a plate 38 in which a diagonal slot 52 a is formedsimilarly to the embodiments of FIGS. 1 to 39. Accordingly, this aspectof the embodiment will not be described in further detail.

An expelling means 51 is provided in the form of a ram with a circulardisc 52 to engage with the plunger of a cartridge in order to dispense aliquid medicament therefrom.

A drive element 48 is provided. The drive element 48 comprises an arm 48a connected towards the proximal end thereof to a pivot point 49 formedin the body 55 of the mechanism. At the distal end of the drive elementof driver, a circular protrusion or follower 52 a is provided whichengages with the diagonal slot 10 a in the plate 38 of the dosagesetting means 7.

The drive element 48 comprises a further pair of arms 48 b which extendfrom the distal end of the driver 48 in the proximal direction of themechanism and device and angled relative the arm 48 a connected to thepivot point 49. Each of the pair of arms 48 b comprises at theirproximal, free ends, a drive pawl 48 c.

The expelling means 51 comprises a rack of teeth 54 which are formed toengage with the teeth 47 c of a drive wheel 47. The drive wheel 47 has acentral section 47 c formed as a gear wheel which engages with the teeth54 of the rack of the expelling means 51.

The drive wheel 47 is formed with two ratchet wheels 47 a, 47 b ateither end. The ratchet wheels 47 a, 47 b have a larger diameter to thediameter of the central gear wheel 47 c. The teeth of the ratchet wheelsare offset relative to one another, i.e. the faces of the teeth in oneratchet wheel are offset from the faces of the teeth in the otherratchet wheel. Similarly to the embodiments described in relation toFIGS. 1 to 39, this can provide a finer movement and thus dosage.

Biasing pawls 50 are formed with the body 55 and are angled in theproximal direction of the device. Two such biasing pawls are provided.One upper biasing pawl engages with one of the ratchet wheels 47 a andthe other, lower biasing pawl engages with the other of the ratchetwheels 47 b. It can therefore be seen that these biasing pawls 50 serveto prevent anticlockwise (as seen in FIGS. 40 m, 41) rotation of thedrive wheel and can therefore be seen to act similarly to the biasingpawls described in relation to FIGS. 1 to 39. The biasing pawls 50 facea common side of the ratchet wheels provided on the drive wheel.

FIG. 40 shows the device 1 with the push button 7 in a depressedposition. As can be seen from FIGS. 40 and 41, upon withdrawal of thepush button 7 into the withdrawn position as shown in FIG. 41, theprotrusion 52 a on the driver 48 follows the diagonal slot 10 a suchthat the driver 48 is caused to rotate anticlockwise about the pivotpoint 49. In so doing, the drive pawls 48 c slide over the teeth in theratchet wheels 47 a, 47 b, thus moving into successive valleys formed bythe ratchet teeth. The biasing pawls 50 prevent rotation of the drivewheel in an anticlockwise direction during this movement of the drivepawls.

Upon the subsequent depressing of the push button 7 in the axialproximal direction, the driver 48 is caused to rotate about the pivotpoint 49. Due to the offset of the ratchet teeth in the ratchet wheels47 a, 47 b, only one of the drive pawls 47 a, 47 b engages fully with anengaging face of one of the ratchet wheels 47 a, 47 b and rotates theratchet wheel 47 about its axis 56 in a clockwise direction as viewed inFIG. 41.

As the drive wheel 47 rotates, the gear teeth 47 c, which are engagedwith the rack of teeth 54 on the expelling means 51, rotate causing theexpelling means to be displaced in an axial direction to deliver oradminister a dose from the cartridge.

FIG. 42 shows the expelling means 51, driver 48 and drive wheel 47. Dueto the larger relative diameters of the ratchet wheels 47 a, 47 b to thesize of the gear wheel 47 c on the drive wheel 47, the expelling meanssits between the drive arms 48 c of the driver 48. This again allows fora more compact arrangement of components.

FIG. 43 shows a view of the drive wheel 47. Each ratchet wheel 47 a, 47b shares the same axis of rotation as the central gear wheel 47 clocated therebetween. The ratchet wheels 47 a, 47 b may be formedintegrally with the gear wheel 47 c.

As with the embodiments of FIGS. 1 to 39, the drive pawls could beoffset rather than the ratchets on the drive wheel, with the ratchets ofthe drive wheel being in alignment.

Various modifications may be made to the embodiments described withoutdeparting from the scope of the invention as defined in the accompanyingclaims. Furthermore, a skilled person will note that, though the terms“upper” and “lower” are used throughout the description for ease ofreference to the figures, these terms are interchangeable with otherdifferentiating terms for similar or identical features such as “first”and “second”, for example.

1. A dispensing mechanism for administering a dosage of a medicament,the mechanism comprising: a body; and dosage setting means for settingthe dosage of a medicament to be administered, the dosage setting meansbeing moveable in a first direction for setting the dosage and in asecond direction for administering the dosage, wherein the mechanismfurther comprises an indication element, the indication element beingarranged to be displaced by a predetermined movement of the dosagesetting means; and wherein the indication element is configured toremain unmoved relative to said body of the mechanism during at leastpart of said movement of the dosage setting means.
 2. A dispensingmechanism as claimed in claim 1, wherein the indication element ismovable within a guide channel.
 3. A dispensing mechanism as claimed inclaim 1 or 2, wherein the indication element is slidingly supported in,on or by the body.
 4. A dispensing mechanism as claimed in claim 1,wherein the dosage setting means is operatively coupled to conversionmeans in the form of a first and a second engagement means, the firstengagement means and the second engagement means being independentlyengageable with the indication element such that upon engagementmovement of the dosage setting means causes displacement of theindication element.
 5. A dispensing mechanism as claimed in claim 4,wherein the engagement means are arranged spaced apart a distancegreater than the longitudinal length of the indicator element.
 6. Adispensing mechanism as claimed in claim 5, wherein the engagement meansare protrusions formed as part of the dose setting means.
 7. Adispensing mechanism as claimed in claim 1, wherein the dosage settingmeans is linearly displaceable in a direction substantially parallel tothe longitudinal axis of the body.
 8. A dispensing mechanism as claimedin claim 1, wherein the dosage setting means is rotatable about an axissubstantially parallel to the longitudinal axis of the body.
 9. Adispensing mechanism as claimed in claim 1, further comprising resistingmeans arranged to resist movement of the indication element relative tomovement of the dosage setting means.
 10. A dispensing mechanism asclaimed in claim 9, wherein the resisting means comprises a protrusionreceivable in one or more corresponding recesses.
 11. A dispensingmechanism as claimed in claim 1, wherein the mechanism includes anaperture through which at least a portion of the indication element isexposed to a user.
 12. A dispensing mechanism as claimed in claim 1,wherein the indication element comprises tactile and/or visualindications.
 13. A dispensing mechanism as claimed in claim 1, whereinthe indication element is moved directly by the dosage setting means.14. A dispensing mechanism as claimed in claim 1, wherein the indicationelement is moved indirectly by the dosage setting means.
 15. A medicaldevice comprising a dispensing mechanism according to claim 1.